FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
- Recall number
- Z-2203-2019
- Recalling firm
- Medline Industries Inc
- Product
- Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
- Status
- Terminated
- Initiated
- 2019-04-25
- Posted
- not on file
- Terminated
- 2020-12-16
- Reason
- Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
- Root cause
- Other
- Action
- On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees.
- Quantity
- 22204
- Distribution
- US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY
- Lot, serial or model codes
- KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28